2019
DOI: 10.1186/s12955-019-1142-9
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Clostridium difficile Infection–Daily Symptoms (CDI-DaySyms™) questionnaire: psychometric characteristics and responder thresholds

Abstract: Background The purpose of the current study was to determine the final content validation, psychometric characteristics, clinically meaningful improvement, and responder thresholds of the Clostridium difficile infection (CDI)–Daily Symptoms (CDI-DaySyms™) patient-reported outcome (PRO) questionnaire. Methods This validation study was part of two phase III studies (NCT01987895 and NCT01983683) conducted in patients with mild-to-moderate or seve… Show more

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Cited by 5 publications
(10 citation statements)
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References 23 publications
(28 reference statements)
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“…Consequently, health-related quality of life (HrQOL) measures seem particularly important in patients with CDI [ 3 , 5 , 10 ]. There are different generic tools created for patient-reported outcomes [ 11 ] and quality of life [ 4 7 ], however, Cdiff32 is the only instrument specifically developed to assess HrQOL in patients with CDI [ 3 ]. A recently conducted real-world experience study of bezlotoxumab in outpatient infusion centers [ 9 ] provided an opportunity to assess CDI patient-reported quality of life changes from baseline to follow-up using an adapted Cdiff32 survey.…”
Section: Discussionmentioning
confidence: 99%
“…Consequently, health-related quality of life (HrQOL) measures seem particularly important in patients with CDI [ 3 , 5 , 10 ]. There are different generic tools created for patient-reported outcomes [ 11 ] and quality of life [ 4 7 ], however, Cdiff32 is the only instrument specifically developed to assess HrQOL in patients with CDI [ 3 ]. A recently conducted real-world experience study of bezlotoxumab in outpatient infusion centers [ 9 ] provided an opportunity to assess CDI patient-reported quality of life changes from baseline to follow-up using an adapted Cdiff32 survey.…”
Section: Discussionmentioning
confidence: 99%
“…Across the 21 studies, humanistic CDI burden was assessed using four generic and two CDI disease-specific PRO measures designed for use in clinical trials. The generic HRQoL measures were EuroQol EQ-5D-3L (index and visual analogue scale [EQ VAS]) [ 25 , 26 , 30 , 37 ], 36-Item Short Form Health Survey (SF-36)/RAND-36 [ 22 , 29 , 38 40 ], Short Form 6-Dimension (SF-6D) [ 29 ], and National Health Institute’s Patient-Reported Outcomes Measurement Information System—Global Health (PROMIS-GH) [ 25 , 27 , 28 , 41 ]. The CDI disease-specific PROs included the C. difficile Health-Related Quality-of-Life Questionnaire (Cdiff32) [ 16 , 22 , 25 ] and the Clostridium difficile Infection–Daily Symptoms (CDI-DaySyms) [ 27 , 28 ].…”
Section: Resultsmentioning
confidence: 99%
“…The decrement increased significantly with CDI severity, worse for women, and those > 65 years of age. The QALY loss for CDI episode, not integrating excess mortality, was 0.028 (SD 0.053) Paul et al [ 30 ] 2019 69 USA ED-5D-3L Current CDI Antibiotics: ridinilazole vs vancomycin Patients receiving ridinilazole had significant improvement in EQ-5D-3L mean change from baseline in index and EQ VAS scores as early as day 5, but no significant improvements with vancomycin (mean scores not reported) Talbot et al [ 27 ] 2019 168 USA, Canada, Australia, Korea, and Europe CDI-DaySyms ADL, GSRS, PROMIS global items Patients with mild to moderate or severe CDI: pCDI or first recurrence Psychometric validation of the newly developed CDI-DaySyms, a 10-item, 3-domain, CDI disease-specific PRO assessing abdominal symptoms, pain, and systemic/other symptoms Heinrich et al [ 29 ] 2018 2411 USA, EU (UK, France, Germany, Italy, and Spain), China, and Brazil SF-36, SF-6D, WPAI ≥ 18 years old either currently being treated ( n = 299), previously treated ( n = 2111), or never diagnosed with CDI ( n = 350,370) (NHWS data) Current CDI and prior CDI had significantly lower HRQoL relative to never having CDI for SF-36 PCS and MCS and SF-6D (utility). Current CDI and prior CDI missed more work and greater impairment while working and more activity impairment than never having CDI.…”
Section: Resultsmentioning
confidence: 99%
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“…NAP1/ribotype 027) synthesize the actin-ADP-ribosylating toxin known as binary toxin C. difficile transferase (CDT), which leads to the depolymerization of actin filaments, disrupting the actin cytoskeleton in the cytosol [ 16 19 ]. Therefore, the toxins A, B, and CDT can cause severe CDI symptoms [ 20 ].…”
Section: Introductionmentioning
confidence: 99%